Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2020
INTERVENTION: Intervention and Control The CeG intervention will consist of two components: 1) the integration of the TP approach in PC maternal and well‐child visits, with the support of 28 leaflets for parents to file in a folder, plus 2) training for PC providers in their use, based on the TP model. The leaflets were developed to be used by PC providers with parents during the clinical visit. Each will be delivered unitarily in scheduled consultations from 26 weeks of gestation (first TP at third trimester) until the age of 18 months, anticipating TP and some parents' needs, worries/fears maybe not always addressed in healthcare visits. Topics explore several areas (e.g., baby language, sleep, crying, eating, healthy lifestyles, discipline, cognitive development) to contribute to positive parenting. Providers in the CeG arm will complete a 5‐hour training designed to enhance providers’ motivation, skills and self‐efficacy on using different elements of the TP Model as guidance to promote parental competence. For the sessions we developed a set of presentation slides for clinic staff that provides information on the intervention concept and philosophy, implementation and health gains to finally reach practical dimensions inspired by TP approach. Different presentation techniques will be used: interactive activities (individual and group), videos, brainstorming, reflective practice activities. The written material (leaflets) reinforces the TP principles and elaborates on main development challenges of children till the age of six years. One or more clinic representatives will be charged with encouraging and enabling other professionals in their clinic to review the leaflets folder, throughout the study. CONDITION: Parenting abilities ; Not Applicable PRIMARY OUTCOME: ; For Parents:; Parenting sense of competence using the Parenting Sense of Competence Scale (PSOC) at baseline and 18‐months; INCLUSION CRITERIA: 1. Primary Care Providers: Family physicians and family nurses from each site will be recruited if they maintain a regular clinical practice in maternal and child health visits in the PC unit 2. Parents: 2.1. Have a confirmed pregnancy 2.2. Do maternal surveillance with the family doctor and wish to maintain pediatric surveillance of their baby in the PC unit 2.3 Are at least 18 years old 2.4. Are fluent in Portuguese as judged by the consenting provider 2.5. Are able to understand all aspects of the study and provide informed consent 3. Baby/child: children of the participating parents that are born during the study SECONDARY OUTCOME: ; For parents:; 1. Family dynamics (Family Environment Scale – FES); 2. Couple dynamics (Revised Dyadic Adjustment Scale ‐ RDAS); 3. Mental health including depression/anxiety and stress (Depression, Anxiety and Stress Scale‐21 ‐ DASS‐21; Parental Stress Inventory – PSI); 4. Well‐being/quality of life (EUROHIS‐QOL‐8 ‐ QOL); 5. Psychological experience of pregnancy (Pregnancy and Motherhood Attitudes Scale ‐ PMAS); 6. Maternal/paternal attachment (Antenatal Attachment Scale – AAS; Postnatal Attachment Scale – PAS); ; For the Child:; 1. Child development (Baby form; Child form; Child Behavior Checklist ‐ CBCL, 1,5‐5 ‐ parent version); ; For PC Providers:; 1. Effect of the training period namely on providers’ knowledge on TP model, self‐efficacy and intention to use it to better support children and families (PKQ).; ; About the intervention CeG:; 1. Acceptability, satisfaction and feasibility associated with delivering the CeG intervention arm with respect to usual care (Satisfaction Questionnaire – SQ; PC providers/parents version); 2. Evaluation of costs associated with delivering the CeG; ; Assessment timepoints:; First contact with parents in primary care unit, after the study start: Sociodemographic questionnaire; RDAS; QOL; 26‐29 weeks of pregnancy: DASS‐21; 30‐32 weeks of pregnancy: PMAS; AAS; 33‐35 weeks of pregnancy: FES; 36‐40 weeks of pregnancy: RDAS; QOL; Newborn: Baby Form (data collected by PC provider); 1st Month: PSOC; PSI; 2nd Month: DASS‐21; 4th Month: ‐; 6th Month: FES; PAS; 9th Month: PSOC; PSI; 12th Month: ‐; 15th Month: DASS‐21; RDAS; QOL; 18th Month: PSOC; PSI; CBCL; Child Form (data collected by PC provider); Post‐study: Satisfaction Questionnaire;
Epistemonikos ID: 8cedc21894e94cec9d96df88e9cfcb94e113f4a3
First added on: Aug 24, 2024